Recent studies have demonstrated that PPARγ as well as diet control could improve glycemic control, decrease serum ALT level, decrease hepatic fat distribution, and increase intrahepatic insulin sensitivity. The purposes of this study are:

1. Primary aims:

Comparison between Pioglitazone and placebo groups in terms of steatosis and liver function tests.

Evaluation of clinical safety of Pioglitazone

2. Secondary aims:

Comparison between Pioglitazone and placebo groups in terms of liver necroinflammation and fibrosis.

Pioglitazone 30 mg/day for 6 months and 3 months of follow-up period after treatment

Drug: Pioglitazone

Name: GLITOS（Pioglitazone）

Dosage form: Tablets

Dose(s): 30mg

Dosing schedule: QD

Duration: 6 months

Other Name: GLITOS

Placebo Comparator: Placebo

Placebo 30 mg/day for 6 months and 3 months of follow-up period after treatment

Drug: placebo

placebo 30 mg/d for 6 months

Detailed Description:

Pioglitazone belongs to thiazolidinediones and anti-diabetes drug which decreases the insulin resistance. It increases the use of glucose of peripheral tissues and decrease the production of glucose from liver and dose not influence the production of insulin. It is agonist of peroxisome proliferator-activated receptor-gamma (PPARγ) and by binding to the receptors of PPARγ in various tissues it has effects on transcription of the insulin-dependent gene. In animal model, pioglitazone has shown to influence the metabolism by the insulin-dependent mechanism.

Recent studies have demonstrated that PPARγ as well as diet control could improve glycemic control, decrease serum ALT level, decrease hepatic fat distribution, and increase intrahepatic insulin sensitivity. Meanwhile, PPARγ could also prevent the development of alcohol-induced steatohepatitis, improve hepatic necroinflammatory activity, and decrease lipid deposition. It is not yet clearly known how the effect of P-PARγ agonist among Asian peoples.

Eligibility

Ages Eligible for Study:

18 Years to 70 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Main inclusion criteria:

Male and female patients with 18-70 years of age

Liver biopsy findings consistent with the diagnosis of NASH with or without compensated cirrhosis within one year before baseline

Compensated liver disease

Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug

All fertile males and females must be using two forms of effective contraception during treatment during the 3 months after treatment.

Total bilirubin >1.2 x ULN during screening. Patients with history of asymptomatic indirect hyperbilirubinemia whose total bilirubin < 2 x ULN and direct bilirubin < 20% of total bilirubin could be included.

History of prothrombin time > 15 seconds or International normalized ratio (INR) > 1.3

Organ, stem cell, or bone marrow transplant

History of serious concurrent medical illness that in the investigator's opinion might interfere with therapy this includes significant systemic illnesses (other than liver disease) such as chronic pancreatitis

A history of hepatotoxicity to TZDs and/or a history of severe edema or a medically serious fluid-related event associated with the use of TZDs

History of metformin use within 3 months prior to screening.

Type Ⅰ diabetes

Seropositive of HBsAg, anti-HCV or anti-HIV during screening or 3 month prior to screening.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01068444